medical checklists

Development of medical checklistsfor improved quality of patient careBRIGETTE HALES1, MARIUS TERBLANCHE2, ROBERT FOWLER1 AND WILLIAM SIBBALD1

1Sunnybrook Health Sciences Centre, Toronto, Canada, and 2Guy’s & St Thomas’ NHS Foundation Trust, London, United Kingdom

Abstract

Background. Checklists are used in both medical and non-medical industries as cognitive aids to guide users through accuratetask completion. Their development requires a systematic and comprehensive approach, particularly when implemented inhigh intensity fields such as medicine.

Objective. A narrative review of the literature was conducted to outline the methodology to designing and implementingclear and effective medical checklists.

Methods. We systematically searched for relevant English-language medical and non-medical literature both to describe wherechecklists have been demonstrated to improve delivery of care and also, how to develop valid checklists.

Results. The MEDLINE search yielded 8303 citations of which 1042 abstracts were reviewed. On the basis of criteria forinclusion and subsequent full-manuscript review, 178 sources, including 17 non-medical publications, were included in thenarrative review. This information was further supplemented by expert opinion in the area of checklist development andimplementation. A small number of strategies for designing effective checklists were referenced in the literature, includingutilization of pre-published guidelines, formation of expert panels and repeat pilot-testing of preliminary checklists.

Conclusion. Despite currently available evidence, a highly effective, standardized methodology for the development anddesign of medical-specific checklists has not previously been developed and validated, which has likely contributed to theirinconsistent use in several key fields of medicine, despite evidence of their fundamental role in error management.

Keywords: checklist, design methodology, mnemonic device, patient safety, quality improvement

Checklists are used in both medical and non-medicalindustries as cognitive aids to guide users through accuratetask completion. A checklist is an organized tool that out-lines criteria of consideration for a particular process. It func-tions as a support resource by delineating and categorizingitems as a list—a format that simplifies conceptualizationand recall of information [1]. Checklists have proven effectivein various aspects of performance improvement and errorprevention and management [2–5].The development of technical documents, such as check-

lists, requires a systematic and comprehensive approach, par-ticularly when they are to be implemented in high intensityfields such as medicine. However, there is a relative paucity ofpublished technical instructions for medical checklists. Wesearched for relevant English-language medical and non-medical literature both to describe where checklists have beendemonstrated to improve care and delivery and also, how todevelop valid checklists. Within the medical literature, thefocus lies with the development of mnemonic devices andchecklists outlining current evidence-based best practices,although the checklists themselves are rarely included for pub-lication. Of the literature available in non-medical areas, the

focus lies with the design of evaluative checklists and tools forperformance measurement, rather than memory aids or goalssheets. Although a small number of strategies for designingeffective checklists are referred to in the literature—includingutilization of pre-published guidelines, formation of expertpanels and repeat pilot-testing of preliminary checklists—ahighly effective, standardized protocol for checklist develop-ment and design has yet to be developed and validated [6]. Tothat end, we have performed a narrative review of the mosteffective methods used in both medicine and other disciplinesto design clear and effective checklists, as well as examples oftheir efficacy in various environments. We also outline avail-able sources of support information. This perspective willdelineate the standard components of successful checkliststhat can be used as a template in the development of case-specific medical checklists.

Methods

We performed a systematic search using MEDLINE (1966–2006) using the individual terms ‘checklist’, ‘goal sheet’, as

1Address reprint requests to: Brigette Hales, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue C829, Toronto, ONM4N 3M5. Tel: þ416 480-6100 ext 88133; Fax: þ416 480-5385; E-mail: [email protected], [email protected]

International Journal for Quality in Health Care vol. 20 no. 1

# The Author 2007. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved 22

International Journal for Quality in Health Care 2008; Volume 20, Number 1: pp. 22–30 10.1093/intqhc/mzm062Advance Access Publication: 11 December 2007

well as the combined terms ‘checklist AND “memory ORmnemonic”’. Only English language article were included.The search yielded 8303 citations (Table 1). Citations werereviewed for their relevance to the development orimplementation of checklists. Papers for extraction of infor-mation were then selected on the basis of qualitativeinclusion criteria such as the description of a methodologyfor checklist development, the use of the checklist forprocess improvement, clinical support or as a patient safetytool, and the description of overall outcomes followingimplementation in a clinical area. We then selected relevantpapers to provide examples of checklists in medicine and todescribe valid generation of a checklist. We found no ran-domized, controlled trials evaluating checklist development.Additional sources were searched to capture relevant infor-mation from non-medical industries. This included Internetsearches with basic search engines using the search terms‘checklist’, ‘memory’ and ‘mnemonic’. As there is a richhistory of checklist use in aviation and aerospace, we alsosearched the publicly available Federal AviationAdministration (FAA) and National Aeronautics and SpaceAdministration (NASA) literature via their respective organiz-ational web sites (www.faa.gov; www.nasa.gov). We searchedrelevant information from all forms of documentation andliterature that described the design, development, implemen-tation, overall utility and study of checklists in any field orindustry. Information was selected for inclusion based on theoverall credibility of the source, selecting peer-reviewed, uni-versity affiliated or government published documentationwhere possible. In all, 178 sources were selected for detailedreview (Table 1).This evidence was further supplemented with expert

opinion and practical advice. Key content experts inleading areas of checklist research were approached forpersonal interview regarding their experiences with checklistdevelopment methodology, the formatting of technicalinformation, implementation and evaluation of checklistsand additional information relevant to their respectiveindustries. This personal communication was used tofurther substantiate critical points identified in theliterature.

Results and interpretation

Improving patient care: the benefitsof medical checklists

High intensity fields of work, such as the airline industry andthe military, already employ checklists to decrease errors ofomission, improper implementation of procedures and pro-tocols, and to decrease human error under stressful con-ditions [2, 3]. Similar to flight crews and military personnel,healthcare providers must often analyze and manage highlycomplex conditions under demanding and stressful con-ditions [7, 8]. Several areas of healthcare in which complexmedical situations require rapid systematic approaches tocrisis management, such as anaesthesiology and emergencymedicine, therefore already make use of the types of check-lists and memory-aids shown to be beneficial and life savingin the airline industry [9, 10]. Examples of published check-lists currently employed regularly in the medical field includethe checklist for diagnosing brain death [11], the AnaesthesiaGas Machine Checklist [12], the Checklist for the withdrawalof life support and end-of-life care [13] and the FAST HUGchecklist of Clinical Best Practices [14].The use of these checklists and memory-aids in clinical

pathways has been shown to improve the quality of medicalcare [4]. Examples include the prediction of successfulweaning from mechanical ventilation in ICU patients [15],adherence to evidence-based best practices [16] and in theimprovement of patient safety in many clinical areas [17–20].Although the implementation of checklists has not always

directly correlated with significant improvements in patientcare and decreases in human error [21], no published data todate indicate that checklists may contributed to adverseevents, such as imposing a burden on the primary care pro-viders, delays in treatment because of lengthy checklists, orerrors of omission. Rather, they are largely consideredimportant tools to condense large quantities of knowledge ina concise fashion, reduce the frequency of errors of omis-sion, create reliable and reproducible evaluations andimprove quality standards and use of best practices [22].However, there are instances in which excessive use of check-lists could become a hindrance in the healthcare setting. Ifeach detail of every task were targeted for the developmentof a checklist, clinicians may experience ‘checklist fatigue’,whereby they become overburdened with completing theselists. Rather than fulfilling their role as a support resourceand error management tool, checklist use could begin tounnecessarily complicate processes and decrease reliability byadding a secondary layer of complexity. To suggest strictadherence to checklists in all situations is impractical and todo so could compromise the efficacy of a clinical process orprocedure and risk infringing on efficient clinical judgment.Careful selection of checklist topics and consideration ofclinical judgement in the content design process can helpavoid these potential downfalls.Checklists have been important tools in ensuring a consist-

ent standard of care in the medical field. Examples includethe use of standardized order set checklists and daily check

Table 1 Literature search

Medical checklists for improved quality of patient care

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sheets to increase the use of best practices [17, 23]. In onesuch instance, the implementation of daily checklists andreminders in clinical care pathways for inpatients admittedfor acute myocardial infarction or stroke led to significantimprovements in compliance with various key best practicessuch as administration of aspirin in the emergency depart-ment (21.4%; 95% CI; 7.3–32.7%), receipt of beta-blockerswithin 24 h of admission (48.1%; 95% CI; 31.4–64.8%),dysphagia screening within 24 h of admission (40.7%; 95%CI; 21.0–60.2%) and administration of aspirin or clopidogrelto ischaemic stroke patients within 24 h of admission(55.4%; 95% CI; 32.9–77.9%), as compared with the periodprior to study [4]. By formulating case-specific checklistsusing evidence-based criteria and expert judgment, healthcareproviders might be more comfortable knowing they are pro-viding the proven best standard of patient care. If the use ofa checklist or memory tool is subsequently proven to beuseful in decreasing errors, and improving patient or processoutcomes, it can be used to standardize a procedure acrossan organization or field.

Methodology of checklist development

What is a checklist?

A checklist is a list of action items, tasks or behavioursarranged in a consistent manner, which allows the evaluatorto record the presence or absence of the individual itemslisted. Typically, each item is checked off as it is completed,verified, identified or answered, by placing a mark in a desig-nated space. A sound checklist highlights the essential criteriathat should be considered in a particular area. It helps theuser not forget important criteria, achieve standardization of

a process, and enhances an assessment’s objectivity andreproducibility.Despite many uses, checklists are commonly employed as

either mnemonic devices or evaluative tools. Mnemonicchecklists are typically used as a reminder system to helpstandardize normal, abnormal or complex procedures bycalling to mind items, tasks or behaviours typically omittedduring periods of stress or crisis [24]. The benefit of employ-ing checklists as mnemonic devices lies in the fact that theyprovide an organizational framework for quick recall of criti-cal information and current best practices. Evaluative check-lists can be important tools in the standardization ofevaluation by providing the user certain guidelines for theassessment, adding further credibility to and consistencyamong the evaluators [22].Within a strictly medical context, checklists are among

several tools used for process improvement and support ofthe multidisciplinary team. Other resources with a similar goalinclude Clinical Practice Guidelines (CPGs), StandardizedOrder Sets and Pre-printed Protocols or FlowCharts. CPGsprovide a benchmark of what evidence-based best practiceshould be, while protocols systematically describe a precise anddetailed plan or process. Flowcharts fall within the DiagnosticChecklists category, whereby a particular path is followed todetermine an outcome. Although these documents are allcomplimentary and share several properties, checklists typicallyserve the more direct purpose of memory recall and may bemore appropriate for certain discrete tasks. Primarily, medicalchecklists are meant to be mnemonic devices aimed at sup-porting the clinical team through a process with a generaloutline. They are generally more concise than protocols andmay focus on one particular error-prone area and may there-fore be considered more of a support tool than a directive, asare the others forms of clinical resources.

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Table 2 Types of checklists [22]

Type of checklist Description Example

Laundry list Items, tasks or criteria are grouped into related categories withno particular order

Medical equipment checklist

Grocery listSequential or weaklysequential checklist

The grouping, order and overall flow of the items, tasks orcriteria are relevant in order to obtain a valid outcome

Procedure checklist (equipmentmust be gathered beforeprocedure can begin)

Iterative checklist Items, tasks or criteria on the checklist require repeated passesor review in order to obtain valid results, as early checkpointsmay be altered by results entered in later checkpoints

Continued re-checking of thepulse and blood pressure inalgorithms or checklists for adultcardiopulmonary resuscitation

Diagnostic checklist Items, tasks or criteria on the checklist are formatted based on a‘flowchart’ model with the ultimate goal of drawing broadconclusions

Clinical algorithms

Criteria of meritchecklist (COM list)

Commonly used for evaluative purposes, in which the order,categorization and flow of information is paramount for theobjectivity and reliability of the conclusions drawn

Checklist for diagnosis of braindeath

Objective structured clinicalexamination checklist

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What should a checklist look like?

The goal of the checklist will define its structure andcontent. For instance, checklists can be designed for adefined action (i.e. design is based on the overall purpose ofthe checklist), such as those employed in the field of aero-nautics for the standardization of system set-up, shutdownor emergency error correction [25]. These types of checklistsare commonly used to facilitate the identification of errors ofomission, by having several crew/team members runthrough the checklist in a systematic format to ensure eachcheckpoint is completed appropriately with the ultimate goalof properly setting-up a system or correcting an error.Several other types of checklists based on either the sequencein which the contents of the checklist are presented, or theoverall purpose and intention of the checklist exist [22].These are listed in Table 2.

How do I start?

A number of guides are available outlining the propermethods for the design and formatting of successful techni-cal documents [26–29]. These documents include an outlineof the components of an effective checklist, the necessarysteps to create proper checklists and support tools forevaluating the final design. The primary components ofdesigning an effective checklist include basic requirementsfor context, content, structure, images and usability [26, 30].Several other sources make similar recommendations onformatting-related issues such as ensuring that all contentpoints of the document are accurate and evidence-based,employing a correct and consistent writing style relevant tothe content and ensuring it is properly organized based on theultimate goal of the checklist (evaluative versus mnemonic),clear and emphasizing the appropriate information [30, 31].

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Table 3 Considerations for formatting a medical checklist

Criteria Consideration

Context† Location of the checklist should be determined prior to development. If it is to be stored in a medical

record upon completion, the checklist it will need to be processed through the appropriate hospitalregulatory bodies.

Content† When possible, synthesis of published peer-reviewed guidelines and evidence-based best practices should

be considered to form the body of the checklist.† Literature employed for generation of criteria points should be from a broad range of peer-reviewed,

reliable sources and include perspectives of all types/disciplines that represent the continuum ofintended users [36]. This is particularly important if the medical checklist is to be used by all personnelwithin a multidisciplinary team of healthcare providers.

† Checklists should also reflect the local hospital and institution policies and procedures.Structure

† Checkpoints should be presented in a logical and functional order that reflect the sequence or flow ofreal-time clinician activities and regular patient care routines.

† If the checklist is to be part of standard patient care, it might be important to include a checkpoint at theend where two users can sign off that it was completed.† e.g. space for nurses to confirm that the checklist was completed by the physician.

Images† Clear, equally spaced, bold fonts are suggested for letter differentiation and reading comprehension [37].† If colours are to be used—ensure that they are consistent with those commonly used in the intended

environment.† e.g. if red is commonly associated with emergency situations, it should not be used to highlight text

unless it is urgent information.† Checklists should include appropriate institutional logos or letterheads if necessary (e.g. if it is to be

included in the medical record, it will have to match the format of other forms/orders).Usability

† Checklist should not be so onerous or time consuming as to notably interfere with administration ofpatient care.

† Overall checklist should encompass checkpoints of major importance, while still providing clinicians withthe freedom to use their own judgment.

† Members of each discipline within a unit should pilot the checklist, particularly if the checklist is to beused by all personnel within a multidisciplinary team of health care providers.

† Validation of the checklist should occur, where possible, within the appropriate simulated clinicalenvironment.


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The visual effectiveness of a document refers to how theappearance of information and the use of visual elementscan directly influence the overall efficacy of the documentand the ease with which users can understand and use thefinal product [29]. Guidelines on visual effectiveness outlinedby Hargis et al. include selecting appropriate graphics,balancing the number and placement of visual elements,appropriate use of colours and shading and textual elements[32]. Other important considerations outlined by key check-list developers include readability, employing nomenclaturefamiliar in the domain of focus for efficient communication,creating a focus on the critical process items and closelyconsidering the expertise of the target user in the develop-ment process (Boorman, November 2005).Medical checklists require specific considerations for suc-

cessful formatting, as listed in Table 3. Importantly, whenformatting a medical checklist, real-time user activities and

state of mind must be factored into the design. Busy clini-cians may be calling upon the checklist under emergent con-ditions to help recall certain life-saving best practices orcritical steps of an infrequently used procedure and willrequire the information to be straightforward and closelyrepresentative of their normal thought pattern.Owing to the lack of description of the development of

medical-specific checklists, we sought expert opinion frominfluential members of the aeronautic, medical and academiccommunities to elucidate the approach used to design thechecklists that are useful in these work environments. A briefsummary of the dialogues is outlined in Table 4.A detailed process guide to developing evaluative checklists,

created by Stufflebeam et al. delineates the steps required todetermine, classify and refine checklist content, to review andevaluate the efficacy of the checklist and the measures tomaintaining a valid checklist [27]. Other sources also touch

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Table 4 Expert opinion on the checklist development process - summarized from personal communications

Discipline Summary of process and expert opinion

Medicine† Co-authors of the Pocket Medicine program ‘Checklists in Internal Medicine’ for personal digital

assistants [PDA] employed a general opinion-based methodology for the design and development of thechecklists.

† Content was determined based on professional medical experience, primary literature sources and/orpeer-reviewed guidelines and consensus of colleagues in the field of interest.

† Checkpoints were designed in a ‘question’ format to engage the user in an interactive manner, withsimilar topics or questions repeated for several of the conditions to create flow and consistency.

† Flow of the checkpoints was arranged to reflect the approaches used in the general evaluation ofpatients.

† The final structure of the checkpoints was designed based on size constraints presented by the PDA.† No pilot testing of the checklists was performed prior to their approval and programming due to time

constraints.Aeronautics

† Technical Fellow in the Boeing Flight Technical Services group & designer of the electronic checklistused on Boeing 777 Aircraft.

† Paper-based manual of checklists was used as the basis for developing the aircraft electronic checklistsystem.

† Checklist content should take into consideration: readability aspects, simplicity requirements, criticalitems of focus, nomenclature familiar in the domain, expertise of the user.

† Validation is KEY. Simulators are used with the checklist to repeatedly run the checklist in theanticipated arena.

† Each part of a checklist should be real time and follow the thought process of the user.† It is important to understand why the user would want the checklist—and set-up the checklist [paper or

electronic] accordingly to help, not hinder, the process covered by the checklistAcademia

† Director and members of the Evaluation Centre (Western Michigan University) and authors ofnumerous checklist-related documents [22, 26, 27].

† Checklist development should include the following considerations:† Strong external review of format, content, design;† Hearings to determine content (expert consensus);† Testing, rigorous validation processes;† Advisory board to drive and guide the development process;† Buy-in of users is integral in success of the checklist.

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upon the processes by which a checklist or other discipline-specific technical documents come into fruition [30, 33, 34].Several make similar recommendations with respect toformat, design and organization of technical documents.

Content development will depend on the context in which thechecklist is to be used. However, components of the develop-ment process consistent with all disciplines include the earlyidentification of the desired use of the checklist, rigorous

Figure 1 Sample medical checklist.


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evaluation of current literature and practices to create the corecontent points and rigorous validation of the checklist ortechnical document prior to implementation.Although the processes outlined in the literature and

expert consensus can be applied to the development ofchecklists in any field of work, (similar to the formattingrequirements) there are particular considerations when creat-ing a checklist for use by medical professionals. For instance,designers should understand the conditions under which theclinician would be referring to or completing the checklist inorder to determine the appropriate content and flow. Similarmedical-related points include:(i) Ensuring that the time required to complete the

revised checklist is feasible, practical and does notinterfere with time-to-delivery of appropriate and safepatient care.

(ii) Ensuring that the checklists pass through appropriateadministrative or regulatory authorities (e.g. HospitalMedical Advisory Committee or Policy andProcedures).

(iii) Provide clinicians with freedom to use their clinicaljudgment.

(iv) Checklists should be reviewed frequently to reflectupdates in the evidence-based medicine, publishedguidelines and institutional policies and procedures.

Fig. 1 outlines a clinical checklist of evidence-based proceduralbest practices, developed based on these considerations.It is also important to consider the broader organizational

processes and overall improvement goals when determiningthe focus, purpose and placement of a checklist. They arenot appropriate in all environments and where they can beselectively implemented, should focus on key areas or tasks

commonly prone to error or omission, so as to improveaccuracy, adherence to best practice and overall processreliability.

Final considerations

Regardless of the systematic approach used to design anddevelop the perfect checklist, there are subsequentmeasures that, if not considered, could jeopardize theimplementation of the checklist into practice. For instance,users must be properly trained on the use of the checklistin order to achieve optimal results. Target users must alsohave a full understanding of purpose of the checklist,whether it be evaluative or mnemonic, to avoid misinter-pretation of checkpoints and erroneous answers. Thechecklist must be extensively piloted, ideally in simulatedclinical environments and amongst the population of usersin order to evaluate efficacy, practicality and overall needfor the checklist (Boorman, November 2005). Checklistdesigners or authors might also consider developing aneducational plan that introduces the main concepts of thechecklist to the candidate users, in combination with a pro-motional plan to increase awareness of the checklist. Theefficacy of a checklist at altering practice is ultimatelydependent on the commitment by the users to employ thechecklist. Usefulness of the checklist requires support of allstaff, dedicated champions and endorsement by multidisci-plinary leaders in clinical care [35]. Inclusion of the multidis-ciplinary team during the development of checklists not onlyimproves endorsement, but also contributes to long-termsustainability following implementation and further empha-sizes a team approach to completion and ‘cross-checking’ of

Figure 2 Key lessons learned for medical checklist development.

B. Hales et al.

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the checklist items, a component that is integral in theaviation industry in preventing errors of omission.

Conclusions

Checklists can serve as important tools for decreasingmedical error and improving overall standards of patientcare, particularly during stressful conditions when memory,vigilance and cognitive functions can be affected. The devel-opment of effective checklists involves several importantsteps (Fig. 2). Legitimacy of the content will depend on theprocess for its development, and should include a thoroughreview and evaluation of the literature, evaluation of currentpractices and consideration of expert consensus, as well as athorough validation of the checklist in the target user popu-lation prior to implementation of the final document.Checklist development should not be static, but an ongoingprocess involving expert groups, up-to-date literature, andfeedback from the intended users as well as the target audi-ence. When all staff members that might interact with thechecklist have been involved in the process of creating anddesigning the checklist, there is a feeling of ownership of thechecklist. The items contained in the final checklist representa consensus between all members of the team, and improveimplementation and uptake of a checklist into daily practice[28]. The lack of literature outlining the methodologyand special considerations for developing medical-specificchecklists has likely contributed to their continued absence inseveral key fields of medicine, despite evidence of their fun-damental role in error management. Further areas ofresearch in the utilization of checklists should focus on theevaluation of checklist fatigue in healthcare, the impact ofchecklist usage from the patient perspective, the continuedevaluation of outcome improvements and direct tracking oferror rates for the respective checklist focus.

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Accepted for publication 4 November 2007

B. Hales et al.

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medical checklists